Per FDA guidelines Medical Device companies are required to establish complaint-handling procedures to detect, evaluate and appropriately address possible product-related problems. For the manufacturer, effective complaint handling is a complex and time-consuming process that integrates data collection, evaluation and risk assessment. eMDR is an effective reporting mechanism for handling complaints. Kacera’s presentation will examine the eMDR implementation process and how to benefit from eMDR.

“eMDR is an incredibly useful tool to help your company more effectively handle complaint reporting,” Kacera said. “Proper knowledge and planning will save your company’s valuable resources, time and frustration. If a company correctly implements an eMDR process, it can be one of the front-line defenses against serious complaint system weaknesses.”
The FDAnews virtual conference will be held Thursday, March 28, 2013, from 10 a.m. to 4 p.m. EDT and features four back-to-back sessions dedicated to complaint handling and best practices for running the complaint department. To register, visit http://www.fdanews.com/conferences.

About Pilgrim Software, Inc.

Pilgrim Software, the world leader of cloud and on-premise enterprise solutions for quality and compliance management, delivers integrated applications for pre- through post-market operations of Life Sciences companies. For more than a decade, Pilgrim's tightly integrated 21 CFR Part 11-compliant system has enabled its clients to proactively manage documents, audits, complaints, nonconformances, corrective/preventive actions, supplier quality, and training, helping ensure product safety and regulatory compliance, reduce manufacturing costs, and improve customer satisfaction. For more information, visit Pilgrim Software’s website at www.pilgrimsoftware.com.